# Classys, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 4 (2023–2026): 4 510(k) clearances
- Product codes: GEI (2), GEX (1), OHV (1)
- 510(k) review time since 2016: median 173 days, against 108 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ilooda Co,., Ltd.: 1 (https://510kreport.com/company/ilooda)
- Medicis Technologies Corporation: 1 (https://510kreport.com/company/medicis-technologies)
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)

## Its most-cited devices
- K240248: Volnewmer™ (2024), cited by 1

## Recent decisions
- K253504: Volnewmer™ (Jul 13, 2026)
- K253123: CuRAS hybrid (Nov 20, 2025)
- K240248: Volnewmer™ (Apr 29, 2024)
- K230100: Scizer (SC1-M410) (Nov 3, 2023)

Source page: https://510kreport.com/company/classys